Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT

K-Number: K870089 · 1987-03-17

ApplicantMicroscan Div. Baxter Healthcare Corp.
Decision Date1987-03-17
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microscan Div. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870089. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT?

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Microscan Div. Baxter Healthcare Corp.. The 510(k) number is K870089.

When did IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT receive FDA 510(k) clearance?

IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870089.

Who is the listed applicant for IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT?

The FDA 510(k) record lists Microscan Div. Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT?

The FDA product code for IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT is GTJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Microscan Div. Baxter Healthcare Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3K871229ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELLK871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AK871228ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BK871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1

View all 11 devices →

Related Devices (Code: GTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952791DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems PreanalyticK915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK910210SLIDEX MENINGITE-KIT 5Vitek Systems, Inc.K885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome DiagnosticsK854852WELLCOGEN BACTERIAL ANTIGEN KITWellcome Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑